Cardiovascular Systems, Inc. Announces Development of Intravascular Lithotripsy Technology for the Treatment of Coronary and Peripheral Artery Diseases
January 13 2022 - 4:05PM
Business Wire
Complementary technology to orbital
atherectomy expands CSI’s vessel prep market opportunity
Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical
device company developing and commercializing innovative
interventional treatment systems for patients with peripheral and
coronary artery disease, announced today it has made significant
progress towards the commercialization of intravascular lithotripsy
(IVL) systems for the treatment of calcific coronary and peripheral
artery disease.
Lithotripsy is a medical procedure that uses non-invasive
high-pressure waves to fracture and disrupt pathologic solid
masses. Lithotripsy has been used successfully for many years in
the treatment of kidney and gall stones, and more recently has
found application in treatment of calcified coronary and peripheral
arteries.
Feasibility testing of a proprietary console and associated IVL
balloon catheters is complete. The CSI IVL systems are designed to
improve upon the limitations of incumbent technology, allowing
physicians to cross and treat more challenging atherosclerotic
lesions.
Commercialization of the IVL systems will be highly
complementary to CSI’s broader portfolio of advanced vessel
preparation technologies.
In coronary, CSI’s current product offering, which is focused on
the treatment of severely calcified coronary arteries using orbital
atherectomy, targets 12% of percutaneous coronary interventions
(PCI). The addition of a coronary IVL system will enable CSI to
offer products that effectively treat a broader range of calcific
coronary lesions, tripling CSI’s total addressable market (U.S.) to
$1.3 billion. Enrollment of patients in an investigational device
exemption study for the CSI coronary IVL system is currently
targeted for calendar 2023.
CSI’s peripheral orbital atherectomy devices are primarily used
by physicians to treat long, diffuse calcified arteries below the
knee. Introducing a peripheral IVL system to the CSI offering will
expand its treatable patient population across an even broader
spectrum of calcified arteries above and below the knee, thereby
increasing CSI’s addressable market (U.S.) by over 50% to nearly $1
billion. CSI plans to begin first in-human experience for the
peripheral IVL system in calendar 2023.
Scott R. Ward, Chairman, President and CEO, said, “The
development of an IVL system for the treatment of coronary and
peripheral artery disease will uniquely position CSI to provide the
right device, for the right lesion, for all physicians. We believe
the successful execution of this program will greatly expand
patient access to care and CSI’s overall market position in complex
coronary and peripheral disease.”
About Cardiovascular Systems, Inc.
Cardiovascular Systems, Inc., based in St. Paul, Minn., is a
medical device company focused on developing and commercializing
innovative solutions for treating vascular and coronary disease.
The company’s orbital atherectomy system treats calcified and
fibrotic plaque in arterial vessels throughout the leg and heart
and addresses many of the limitations associated with existing
surgical, catheter and pharmacological treatment alternatives. For
additional information, please visit www.csi360.com and connect on
Twitter @csi360.
About Coronary Artery Disease (CAD)
CAD is a life-threatening condition and a leading cause of death
in men and women globally. CAD occurs when a fatty material called
plaque builds up on the walls of arteries that supply blood to the
heart. The plaque buildup causes the arteries to harden and narrow
(atherosclerosis), reducing blood flow. The risk of CAD increases
if a person has one or more of the following: high blood pressure,
abnormal cholesterol levels, diabetes, or family history of early
heart disease. According to the Centers for Disease Control and
Prevention, 18 million people in the United States have CAD, the
most common form of heart disease. Heart disease claims more than
650,000 lives in the United States each year. According to
estimates, arterial calcium is present in 38 percent of patients
undergoing a PCI. Significant calcium contributes to poor stent
delivery, expansion and wall apposition leading to poor outcomes
and higher treatment costs in coronary interventions when
traditional therapies are used, including a significantly higher
occurrence of death and major adverse cardiac events (MACE).
About Peripheral Artery Disease (PAD)
Eighteen to 20 million Americans, most over age 65, suffer from
PAD, which is caused by the accumulation of plaque in peripheral
arteries reducing blood flow. Symptoms include leg pain when
walking or at rest. Left untreated, PAD can lead to severe pain,
immobility, non-healing wounds and eventually limb amputation. With
risk factors such as diabetes and obesity on the rise, the
prevalence of PAD is growing at double-digit rates.
Safe Harbor
Certain statements in this news release are forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995 and are provided under the protection of the
safe harbor for forward-looking statements provided by that Act.
For example, statements in this press release regarding (i) the
development of new IVL systems; (ii) targeted milestones in
calendar 2023; (iii) the benefits of IVL and the new IVL systems;
(iv) the ability of CSI to successfully develop the IVL systems;
(v) the future impact of adding the IVL systems to CSI’s portfolio;
and (vi) potential addressable market sizes and expansion of market
opportunities, are forward-looking statements. These statements
involve risks and uncertainties that could cause results to differ
materially from those projected, including, but not limited to,
successful collaboration on the development of the new IVL systems;
agreements with development partners, advisors and other third
parties; the ability of CSI and these third parties to meet
development, contractual and other milestones; contractual rights
and obligations; technical challenges; regulatory developments;
clinical trial requirements and results; FDA requirements,
clearances and approvals; the experience of physicians regarding
the effectiveness and reliability of products sold by CSI; the
reluctance of physicians, hospitals and other organizations to
accept new products; the impact of competitive products and
pricing; intellectual property protections; general economic
conditions; and other factors detailed from time to time in CSI’s
SEC reports, including its most recent annual report on Form 10-K
and subsequent quarterly reports on Form 10-Q. CSI encourages you
to consider all of these risks, uncertainties and other factors
carefully in evaluating the forward-looking statements contained in
this release. As a result of these matters, changes in facts,
assumptions not being realized or other circumstances, CSI's actual
results may differ materially from the expected results discussed
in the forward-looking statements contained in this release. The
forward-looking statements made in this release are made only as of
the date of this release, and CSI undertakes no obligation to
update them to reflect subsequent events or circumstances.
CSI is a registered trademark of Cardiovascular Systems, Inc.
All other trademarks cited herein are owned by their respective
owners.
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version on businesswire.com: https://www.businesswire.com/news/home/20220113005145/en/
Cardiovascular Systems, Inc. Jack Nielsen Vice President,
Investor Relations & Corporate Communications (651) 202-4919
j.nielsen@csi360.com
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